MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø27X35

Model Number	04.01.0156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 june 2026 04.01.0156 glenoid baseplate - d 27x35 (k170452) lot.2508600: (b)(4) items manufactured and released on 29 july 2025.Expiration date: 09 july 2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.04.01.0173 glenosphere - d 39x27 (k170452) lot.2517435: (b)(4) items manufactured and released on 16 october 2025.Expiration date: 30 september 2030.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation revision about 5 month after the primary due to a fractured acromium and it is unknown how this occured.The fracture may have happened due to lateralization of the prosthesis as no traumatic event has been reported but we have no sufficient data to exclude it.Additionally, from the radiographic image the bone quality seems low, and this can be also the cause of the fracture of the acromion.There is no reason to suspect a malfunctioning device.Root cause:based on the information available, no definitive root cause can be established.The device history record review did not indicate any potentially related manufacturing issue.The event may be related to case-specific clinical factors, including prosthesis lateralization and/or low bone quality.
Event or Problem Description
Postoperative acromion fracture occurred approximately 5 months after the primary surgery.The patient is being treated conservatively.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID BASEPLATE - Ø27X35
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25528751
• Report Number: 3005180920-2026-00570
• Device Sequence Number: 9744144
• Product Code: PHX
• UDI-Device Identifier: 07630040706438
• UDI-Public: 07630040706438
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0156
• Device Lot Number: 2508600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 88 KG